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Old 12th January 2018, 10:02 AM
fondantcookie

 
 
Total Posts: 18
Please Help! Class IIa/b in-country registrations x5 ?

Hi all.

We have two devices that we are wanting to sell within the following 5 countries:

South Africa
Iran
Israel
Kuwait
UAE

One of the devices is Class IIa and the other Class IIb (per the Medical Device Directive).

I know some countries within the EU (my main focus) require additional in-country registration/notification, but does anyone know if there is anything additional for these countries?

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